Clinical Experimentation With Tenofovir Disoproxyl Fumarate and Emtricitabine for COVID-19

NCT04712357 | Unknown

• 1 other identifier: CAAE: 34182620.0.0000.5045
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical, control, double-blind, randomized trial with tenofovir disoproxyl fumarate and emtricitabine for Covid-19

Conditions

Covid19

Keywords

Tenofovir; Emtricitabine; COVID-19; Clinical trial

Outcome Measures

Primary Outcomes (1)

• The time to recovery, defined at day 7 days follow up after enrollment, on which a patient met the criteria for category 1, 2, or 3 on the eight-category ordinal scale.

  The categories are as follows: 1 - No signals and symptoms; 2 - One signal or symptom; 3 - Two signals or symptoms; 4 - Three or more signals or symptoms; 5 - Hospitalized, no active medical problems; 6 - Hospitalized, not on oxygen; 7 - Hospitalized, on oxygen; and 8 - Hospitalized, on high flow oxygen.

  Day 7 follow up after enrollment.

Secondary Outcomes (3)

• SARS-CoV-2 RNA viral load measurements change.

  Change between Day 1 and Day 7 follow up after enrollment.

• Proportion of patients with qualitative serum IgM / IgG.

  Proportion of positive patients at Day 28 for IgM / IgG (N; %).

• Biomarkers (IL-6, MCP-3, D-dimer, IL1-RA, IL-10, GCSF, TNF-α, MCP-1, IL-2R, MIP-1 alpha, IP-10, IL-8, NT-proBNP, Troponin I, CRP and procalcitonin) measurements change.

  Change between Day 1 and Day 14 follow up after enrollment.

Study Arms (3)

Placebo (Vitamin C)

PLACEBO COMPARATOR

Control placebo (Vitamin C - 500mg / day, for 10 days)

Drug: Vitamin C 500 MG Oral Tablet

Tenofovir disoproxyl fumarate (TDF)

ACTIVE COMPARATOR

Tenofovir disoproxyl fumarate (TDF; 300 mg / day, for 10 days)

Drug: Tenofovir disoproxyl fumarate 300 MG Oral Tablet

TDF + FTC

ACTIVE COMPARATOR

Tenofovir disoproxyl fumarate (TDF; 300 mg / day, for 10 days) plus emtricitabine (FTC; 200 mg / day, for 10 days)

Drug: Tenofovir disoproxyl fumarate 300 MG plus emtricitabine 200 MG Oral Tablet

Interventions

Vitamin C 500 MG Oral Tablet DRUG

Vitamin C 500 MG per day for 10 days

Placebo (Vitamin C)

Tenofovir disoproxyl fumarate 300 MG Oral Tablet DRUG

Tenofovir disoproxyl fumarate 300 MG per day for 10 days

Tenofovir disoproxyl fumarate (TDF)

Tenofovir disoproxyl fumarate 300 MG plus emtricitabine 200 MG Oral Tablet DRUG

Tenofovir disoproxyl fumarate 300 MG plus emtricitabine 200 MG per day for 10 days

TDF + FTC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is \> 18 years old
• Patient diagnosed with COVID-19

You may not qualify if:

• Patient is already receiving some of the study drugs
• There is a hospitalization plan in the next 24h
• Some study treatment is contraindicated
• Patient has HIV infection
• Patient has VHB infection
• Patient lives in another city or state
• Female patient, pregnant

Sponsors & Collaborators

• Universidade Federal do Ceara: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• São José Hospital for Infectious Diseases - HSJ: collaborator
• Central Laboratory of Public Health of Ceará - Lacen-CE: collaborator

Study Sites (1)

Núcleo de Biomedicina - NUBIMED

Fortaleza, Ceará, 60430270, Brazil

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Ascorbic Acid; Tablets; Emtricitabine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Dosage Forms; Pharmaceutical Preparations; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Aldo AM Lima, Ph.D.

CONTACT

5585987042833; alima@ufc.br

Alexandre H Binda, Ph.D.

CONTACT

5585987565695; ahavt@ufc.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomized double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Control case

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 15, 2021
• Study Start: November 9, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)